Device for Collecting, Transferring, and Storing Samples of a Biological and/or Chemical Material

ABSTRACT

A device for collecting, transferring, and storing samples of a biological and/or chemical material, wherein the device comprises: a support body, developing along a main longitudinal direction between a first end and a second end opposite to each other and connected by an intermediate portion elongate in the main longitudinal direction, a collection portion engaging the first end and configured to collect a quantity of a sample of a biological and/or chemical material, the collection portion being defined at least by a first coating layer realized on the first end and made from an elastically deformable material and by a second coating layer consisting of a layer of flocked fibers, the second coating layer being realized through a fiber flocking process on the first coating layer and being configured to absorb a quantity of liquid including at least one sample of a biological and/or chemical material.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of and claims the benefit of priorityto U.S. patent application Ser. No. 15/772,245, filed on Apr. 30, 2018,which is a U.S. National Phase application under U.S.C. § 371 and claimsthe benefit of priority to International Application No.PCT/IB2016/056340, filed Oct. 21, 2016, which claims priority to ItalianPatent Application No. IT102015000068584, filed Nov. 3, 2015, thecontents of which are hereby incorporated by reference.

DESCRIPTION

The concepts herein refer to a device for collecting, transferring, andstoring samples of a biological and chemical material. The conceptsherein also concern a kit comprising such device and a method forcollecting, transferring, and storing samples of a biological and/orchemical material by such device and such kit. The concepts herein alsoconcern a method for implementing a device for collecting, transferring,and storing samples of a biological and/or chemical material. Theconcepts herein find, for instance, a particular application forcollecting, transferring and/or storing buccal and/or lingual samples,but it can also be applied to numerous further sample collecting types.The use of various types of collection devices, which are provided atleast with a collection portion suitable for collecting biologicaland/or chemical samples and a support body suitable for making itpossible to handle the collection element itself is known. Collectiondevices are known having collection portions of different types, forinstance made up of cotton fibers wound around a rod, semi-rigid fiberssuitable for scratching a surface and performing a collection in anessentially “mechanical” manner, or an absorbing material of a spongy orfoamy type mounted on the rod, etc. Devices are also known which arereferred to “flocked swabs”, comprising an elongate support body and aplurality of flocked fibers at one end of the support body to define acollection portion suitable for absorbing the mentioned analytes orbiological samples. Such type of device is known from patent EP1608268B1(Triva), deriving from WO2004/086979 Al. Further solutions related tosuch type of product are described in WO2014/207598 (Triva) andWO2015/052607 A1 (Triva). Technical solutions are also known, inparticular in the case of buccal or lingual collections, whereby, aftercollecting a sample of a biological material, the sample itself istransferred onto a different medium suitable for making it possible tostore the sample even for a long period of time. For instance, thepractice is known of transferring the samples collected by way of thementioned collection devices onto matrix media or chemically treatedpapers to make it possible for the samples of material to be absorbedand stored. Such type of papers is known, for instance, from patentapplication WO9003959 (Burgoyne). Technical solutions are also knownwhich make it possible to collect a biological sample and to transfer itonto the mentioned storage papers by way of an appropriate kit, whichcomprises a collection device as well as a medium to house the storagepaper. Such kits are illustrated, for instance, in patent applicationWO2008/099196 (Harvery) and in patent application WO2014/001940 (Triva)corresponding to US2013/344616 A1. Such solutions support thepossibility of moving, in a controlled manner, the collection devicefrom a sample transfer position, where it is in contact with the storagepaper, to a rest and transfer position, wherein such elements are spacedaway. However, a correct transfer of samples and a correct operation ofsuch kits might be difficult in some situations. As a matter of fact, acorrect transfer of a collected sample from the collection portion ofthe collection device to the storage paper, or to another medium, isaffected by numerous factors, among which: the material and thearrangement of the collection portion of the collection device, the typeof the paper, the material and the shape of the kit housing bodyaccommodating the storage paper and the collection device, the degree ofelasticity of the movable portion that the collection device is coupledwith, the force that is applied by a user to make the collection portionand the storage paper get closer, and so on.

Consequently, in some cases a transfer might take place incorrectly, ina non-homogeneous manner, or to an insufficient extent, and this mightentail even severe consequences in term of reliability of the analysisperformed on a sample and a complete traceability thereof. The mainobject of the concepts herein is to solve one or more of the problemsencountered in the known art. An object of the concepts herein is toprovide a device and a method for collecting, transferring, and storingsamples of a biological and/or chemical material that make it possibleto guarantee a reliable and completely traceable storage of thecollected sample. Another object is to provide a device and a methodthat offer a high reliability in any conditions of use and as muchindependent as possible of the mode of use by a specific professionaluser. Another object is to provide a device and a method that allow foran optimum transfer of a collected sample from a collection device to astorage paper or to another storage or analysis medium. Another objectis to provide a device and a method that are easy to use. It is also anobject of the concepts herein to provide a device and a method that makeit possible to minimize the risk of contamination for the collectedsamples. It is a further object of the concepts herein to provide adevice and a method that are simple and economical to implement. Theseobjects and others, which will be more apparent from the followingdescription, are substantially achieved by a device and by a method forcollecting, transferring, and storing samples of a biological and/orchemical material according to the contents of one or several of theattached claims, taken alone or in any combinations between them, or inany combinations with one or more of the further aspects describedbelow. Further aspects of a device for collecting, transferring, andstoring samples of a biological and/or chemical material, which can betaken in any combinations between them and/or with the attached claims,are expressed below. In a further aspect, combinable with any of theattached dependent claims of the device and/or with any of the furtheraspects indicated below, the concepts herein also concern a device forcollecting, transferring, and storing samples of a biological and/orchemical material, wherein the device comprises a support body,developing along a main longitudinal direction between a first end and asecond end, opposite to each other and connected by an intermediateportion featuring an elongate shape in the main longitudinal direction;a collection portion engaging the first end and configured to collect aquantity of a sample of a biological and/or chemical material, whereinthe collection portion is defined at least by a first coating layerrealized on the first end made from an elastically deformable materialand wherein the first coating layer consists of a plurality of separatesub-portions and/or is provided with a plurality of pre-indentedsub-portions and/or is provided with indentations realized so as todefine a plurality of at least partially separate sub-portions, so as tofacilitate the detachment of at least one individual sub-portion of thefirst coating layer, and of a corresponding sub-portion of the secondlayer, from the first end at a time following the sample collectiontime. In a further aspect, the collection device is a device for abuccal collecting of samples. In a further aspect, the collection deviceis a swab. In a further aspect, the collection device is a buccal and/orlingual swab. In a further aspect, the collection portion is configuredto absorb a sample of a biological and/or chemical material. In afurther aspect, the first coating layer is made from a synthetic sponge.In a further aspect the first coating layer is made from an expandedresin. In a further aspect, the first coating layer is made from one ormore of the following materials: expanded polyethylene, EVA, LDPE,expanded polyurethane, polyether, polyester, Stratocell® (a laminatedpolyethylene foam, which can have a closed-cell structure and havelow-density, medium density or high density), antistatic, FOAM,Plastazote® (a closed-cell cross-linked polyethylene foam), rubbermousse, latex, Dryfeel® (an opel cell reticulated polyether foam whichcan be treated with biocide against bacteria and fungi). In a furtheraspect, the first layer is made from a liquid-impermeable and/orhydrophobic material. In a further aspect, the first layer isliquid-impermeable. In a further aspect, the first layer is madeliquid-impermeable by coating it with an adhesive material. In a furtheraspect, the first layer is made from an hydrophobic material of a“coarse grain” type and/or having “big-size cells”. In a further aspect,the first layer is made from a sponge of a “coarse grain” type and/orhaving “big-size cells”. In a further aspect, a first layer of anadhesive material is provided between the first coating layer and thefirst end to attach the first coating layer at least to the front faceof the first end. In a further aspect, a second layer of an adhesivematerial is provided between the first coating layer and the secondcoating layer, to make it possible for the flocked fibers to adhere tothe first coating layer. In a further aspect, the adhesive material is avinylic adhesive. In a further aspect, the front face and the rear faceare substantially equal to each other and/or symmetrical. In a furtheraspect, the thickness of the first end, as measured between the firstface and the second face and/or in a direction perpendicular to thefirst face and/or to the second face, ranges from 0.5 mm to 5 mm, orfrom 0.7 to 4 mm, or from 1 to 2.5 mm.

In a further aspect, the surface of the front face and/or of the rearface ranges from 20 mm² to 1250 mm², or from 80 mm² to 700 mm², or from120 mm² to 400 mm². In a further aspect, the width of the front faceand/or of the rear face, in a direction perpendicular to the mainlongitudinal direction, ranges from 5 mm to 40 mm, or from 10 mm to 30mm, or from 12 mm to 22 mm. In a further aspect, the diameter of thefront face and/or of the rear face ranges from 5 mm to 40 mm, or from 10mm to 30 mm, or from 12 mm to 22 mm. In a further aspect, the length ofthe fibers of second coating layer thickness of the second coating layeris less than 3 mm, or less than 2 mm, or less than 1 mm. In a furtheraspect, the length of the fibers of the second coating layer thicknessof the second coating layer is greater than 0.3 mm, or greater than 0.45mm, or greater than 0.6 mm.

In a further aspect, the first coating layer completely covers the frontface of the first end. In a further aspect, the first coating layercompletely covers the rear face of the first end. In a further aspect,the first coating layer completely covers the first end. In a furtheraspect, the second coating layer completely covers the first coatinglayer. In a further aspect, the first coating layer covers at least 10%,or at least 30%, or at least 50%, or at least 70% of the front face ofthe first end. In a further aspect, the first coating layer covers 100%,or less than 90%, or less than 80%, or less than 70% of the front faceof the first end. In a further aspect, the second coating layer coversat least 10%, or at least 30%, or at least 50%, or at least 70% of thefront face of the first end. In a further aspect, the second coatinglayer covers 100%, or less than 90%, or less than 80%, or less than 70%of the front face of the first end. In a further aspect, the secondcoating layer covers at least 10%, or at least 30%, or at least 50%, orat least 70% of the first coating layer. In a further aspect, the secondcoating layer covers 100%, or less than 90%, or less than 80%, or lessthan 70% of the first coating layer. In a further aspect, the supportbody is provided, preferably in correspondence with the intermediateportion, with a coupling portion, suitable for making it possible theconnection of the device to an engagement element of a kit forcollecting, transferring, and storing samples of a biological and/orchemical material. In a further aspect, the coupling portion is realizedon the same side as the rear face and on the opposite side with respectto the front face. In a further aspect, the collection portion is alsorealized and engaged to the rear face of the first end. In a furtheraspect, the first coating layer has a surface extension less than thesurface extension of the front face of the first end. In a furtheraspect, the first coating layer has a surface extension less than thesurface extension of the rear face of the first end. In a furtheraspect, the second coating layer has a surface extension less than thesurface extension of the first coating layer. In a further aspect, thefront face and/or the rear face have a perimetric development of thefront face and/or of the rear face, that is curvilinear or substantiallyelliptical or substantially circular or polygonal and substantiallytriangular or substantially quadrangular. In a further aspect, the mainlongitudinal direction coincides with a straight line. In a furtheraspect, the main longitudinal direction is a curved line, and thesupport body has an at least partially curvilinear longitudinaldevelopment. In a further aspect, indentations cut in the first coatinglayer extend in correspondence with at least one part of the thicknessof the first coating layer, in order not to completely separate thesub-portions before collecting a sample. In a further aspect, theindentations extend in correspondence with the full thickness of thefirst coating layer, to completely separate the sub-portions even beforecollecting a sample. In a further aspect, the indentations develop in adirection perpendicular to the surface of the first coating layerintended for receiving the second coating layer.

In a further aspect, the first coating layer features, in correspondencewith at least one sub-portion of the first coating layer, at least oneattachment bulge integral with said sub-portion and suitable for makingthe attachment and the detachment of such sub-portion from the remainingcollection portion, easier. In a further aspect, the attachment bulgeconsists of a tang extending from a lateral surface of the first coatinglayer perpendicular to the surface of the first coating layer on whichthe second coating layer is applied or is intended for being realized.In a further aspect, the support body has a length, in its longitudinalextension, ranging from 50 mm to 200 mm, or from 100 mm to 200 mm, orfrom 145 mm to 155 mm.

In a further aspect, the support body has, in correspondence with thecollecting portion, a diameter in a cross-section perpendicular to itslongitudinal extension ranging from 0.8 mm to 5 mm, or from 1 mm to 4mm, or from 2 mm to 3 mm, or from 2.2 mm to 2.8 mm. In a further aspect,the support body features, in correspondence with the intermediateportion, a diameter in a cross-section perpendicular to its longitudinalextension, ranging from 1 mm to 10 mm, or from 2 mm to 8 mm, or from 3mm to 6 mm, or from 4 mm to 5 mm. In a further aspect, the collectionportion has a length ranging from 5 mm to 40 mm, or from 10 mm to 30 mm,or from 15 mm to 25 mm, or from 12 mm to 20 mm. In a further aspect, lacollection portion has a width, in a direction perpendicular to the mainlongitudinal direction, or a diameter, ranging from 5 mm to 40 mm, orfrom 10 mm to 30 mm, or from 15 mm to 25 mm, or from 12 mm to 22 mm. Ina further aspect, the collection portion is configured to collect orabsorb a substantially known quantity of a sample. In a further aspect,the fibers are arranged on the first coating layer in a substantiallyorderly manner. In a further aspect, the fibers are arranged on thefirst coating layer so as to form a substantially continuous layer. In afurther aspect, the fibers are arranged on the first coating layer so asto define a plurality of capillary interstices suitable for absorbing asample by capillarity. In a further aspect, the fibers feature a countranging from 1 to 10 dtex, or from 2 to 7 dtex, or from 3 to 5 dtex. Ina further aspect, the fibers feature a length ranging from 0.2 mm to 3mm, or from 0.4 mm to 2 mm, or from 0.6 mm to 1.5 mm. In a furtheraspect, the fibers are made from a polyamide (PA or nylon) and/or fromrayon and/or from polyester and/or a carbon fiber and/or from analginate and/or from a natural fiber and/or from cotton and/or from amix of such materials. In a further aspect, the collection portionfeatures a surface density of fibers on the first coating layer rangingfrom 50 to 1000 fiber per mm², or from 100 to 500 fibers per mm². In afurther aspect, the support body is made from a substantially rigid orpartially flexible material. In a further aspect, the support body ismade from a plastic material. In a further aspect, the support body ismade from a plastic polymer or from a co-polyester or from polystyreneor from nylon/polyamide. In a further aspect, the concepts herein alsoconcern the use of a device in accordance with any of theabove-mentioned claims and/or aspects, for collecting, transferring, andstoring a sample of a biological and/or chemical material or forcollecting, transferring, and storing a sample of a buccal and/orlingual biological material. Further aspects of a kit for collecting,transferring, and storing samples of a biological and/or chemicalmaterial, which might be collected in any combinations between themand/or with the attached claims, are expressed below. In a furtheraspect of its own, the engagement element is configured to selectivelyand removably engage the collection device to the housing body, incorrespondence with the housing seat. In a further aspect, theengagement element is configured to selectively and removably engage thecollection device to the operating portion. In a further aspect of itsown, the collection device is provided with at least one couplingportion in correspondence with which it can be selectively and removablycoupled with the engagement element. In a further aspect of its own, theengagement element is configured to removably engage the collectiondevice to the operating portion. In a further aspect of its own, thestorage element is a chemically treated paper suitable for storingsamples of a biological material and/or is a paper comprising at leastone substance suitable for storing a sample of a biological material. Ina further aspect of its own, the engagement element is suitable fordefining at least one first mounting position for the collection devicein correspondence with which a contact and a transfer of a biologicalmaterial take place from the collection portion of the collectingelement to the storage portion. In a further aspect of its own, theengagement element is suitable for defining at least one second mountingposition for the collecting element in correspondence with which thecollection portion is spaced away from the storage portion andconsequently there is no contact nor transfer of a biological materialfrom the collection portion to the storage portion, the second mountingposition also defining a storage and/or transfer position of the device.In a further aspect of its own, the engagement element is configured toselectively and removably engage the collecting element to the operatingportion, so that the collecting element is selectively portable incorrespondence with the housing seat and of the storage portion in thefirst closing position and/or so that the collection portion isselectively portable in correspondence with the housing seat and/or incontact with the storage portion in the first closing position. In afurther aspect of its own, the concepts herein also concern the use of akit in accordance with any of the above-mentioned claims and/or aspects,for collecting, transferring. and storing a sample of a biologicaland/or chemical material or for collecting, transferring, and storing asample of a buccal and/or lingual biological material. In a furtheraspect, the concepts herein concern a method for collecting,transferring and/or storing samples of a biological and/or chemicalmaterial by way of a device for collecting, transferring, and/or storingsamples of a biological and/or chemical material in accordance with theabove mentioned attached claims and/or attached aspects. In a furtheraspect, combinable with any of the attached claims and/or with any ofthe further specified aspects, the concepts herein also concern a methodfor collecting, transferring, and/or storing samples of a biologicaland/or chemical material comprising at least the step of removing, fromthe first end of the support body of the device, a separate orpre-indented sub-portion of the first coating layer and of the secondcoating layer, provided with at least one sample of a biological and/orchemical material. In one aspect, such removal step is performed by wayof an appropriate removal tool, such as tweezers, a lancet, a bladetool, or the like. In one aspect, the method also comprises the step ofsubmitting such separate or pre-indented sub-portion to an analysis orstorage separate from the remaining sub-portions of the collectionportion attached to the first end of the support body. In a furtheraspect, the concepts herein concern a method for collecting,transferring, and/or storing samples of a biological and/or chemicalmaterial by a kit for collecting, transferring, and/or storing samplesof a biological and/or chemical material in accordance with theabove-mentioned attached claims and/or attached aspects.

The method comprises at least the steps of: collecting a sample of abiological material on at least one collection portion of the collectiondevice, then selectively coupling the collection device with a housingbody or with a movable operating portion of the kit, then putting thecollection portion of the collecting element in contact with the storageportion of the storage element for samples of a biological materialhoused in the housing seat of the housing body, to transfer a quantityof the biological material from the collection portion to the storageportion of the storage element. In a further aspect, the method alsocomprises the step of moving the collection portion of the collectingelement away from the storage portion of the storage element and movingthe device for collecting and transferring samples of a biologicalmaterial to a storage and/or transfer position. In a further aspect, themethod also comprises the step of storing a sample of a biologicalmaterial in the storage portion of the storage element for an extendedperiod of time and/or with the device configured in a storage ortransfer position. Further aspects of the method for implementing adevice for collecting, transferring, and storing samples of a biologicaland/or chemical material, which might be taken in any combinationsbetween them and/or with the attached claims, are expressed below.

In a further aspect of the method the support body is realized by way ofan injection molding or extrusion step. In a further aspect, the methodcomprises the step of gluing the first coating layer to the first end.In a further aspect of the method the step of flocking the secondcoating layer onto the first coating layer is performed after applyingthe first coating layer to the first end of the support body.

In a further aspect of the method the step of flocking the secondcoating layer onto the first coating layer is performed before applyingthe first coating layer to the first end of the support body. In afurther aspect of the method the step of flocking the second coatinglayer onto the first coating layer is performed on a sheet of the firstcoating layer and wherein the sheet is subsequently cut into portionshaving appropriate dimensions and subsequently applied to the first endof the support body. In a further aspect of the method the fibers arearranged on the first coating layer by way of a flocking process in anelectrostatic field. In a further aspect of the method the fibers arearranged on the first coating layer substantially perpendicular to thesurface of the first coating layer. In a further aspect of the methodthe fibers are arranged on the first coating layer only incorrespondence with a front surface of the first coating layer. In afurther aspect of the method the fibers are also arranged on the firstcoating layer in correspondence with a lateral surface of the firstcoating layer, perpendicular to the front surface.

In a further aspect, the method also comprises the step of indenting ordinking the first coating layer to define a plurality of sub-portions ofthe first coating layer. In a further aspect of the method the indentingor dinking step is performed so as to realize indentations developing ina direction perpendicular to the surface of the first coating layerintended for receiving the second coating layer. In a further aspect ofthe method the indentation or dinking step is performed before applyingthe first coating layer to the first end of the support body. In afurther aspect of the method the indentation or dinking step isperformed after applying the first coating layer to the first end of thesupport body. In a further aspect of the method the indenting or dinkingstep is performed by cutting the first coating layer down to a depthless than the overall thickness of the first coating layer, so as not tocompletely separate the sub-portions of the first support layer. In afurther aspect of the method the indentation or dinking step isperformed by cutting the first coating layer all along the depth of theoverall thickness of the first coating layer, so as to completelyseparate the sub-portions of the first support layer. In a furtheraspect of the method the indentation or dinking step is performed beforeapplying the second coating layer onto the first coating layer. In afurther aspect of the method the indenting or dinking step is performedafter applying a second layer of adhesive material, suitable forfostering the adhesion of the second coating layer onto the firstcoating layer, on the first coating layer and before implementing thesecond coating layer onto the first coating layer. In a further aspectof the method the indenting or dinking step is performed before applyinga second layer of adhesive material, suitable for fostering the adhesionof the second coating layer onto the first coating layer, on the firstcoating layer and before implementing the second coating layer on thefirst coating layer. In a further aspect of the method the indenting ordinking step is performed after applying the second coating layer on thefirst coating layer. A detailed description of one or several preferredembodiments is now provided, for explanatory, not limitative purposes,wherein:

FIG. 1 is a perspective view of a device for collecting, transferring,and storing samples of a biological and/or chemical material inaccordance with an embodiment of the concepts herein;

FIG. 2 is a front view of the device of FIG. 1;

FIG. 3 shows a side view of the device of FIG. 1;

FIG. 4 shows a kit for collecting, transferring, and storing samples ofa biological and/or chemical material in accordance with an embodimentof the concepts herein, in a disassembled and opened position, thecollection device of FIG. 1 not being coupled with an engagement elementof an operating portion of a housing body;

FIG. 5 shows the kit of FIG. 4, the collection device being coupled withan engagement element of the operating portion;

FIG. 6 shows the kit of FIG. 5 in a position intermediate between theopening position and a closing position;

FIG. 7 shows the kit of FIG. 5 in a closing position;

FIG. 8 shows a detail of the kit of FIG. 5 in a first closing and/orsample contact and transfer position;

FIG. 9 shows a detail of the kit of FIG. 5 in a second closing and/orstorage and transfer position of the kit.

With reference to the figures, the numeral 20 identifies a device forcollecting, transferring, and storing samples of a biological and/orchemical material as a whole. In this context, by “biological material”we also mean a microbiological material. Also, by “biological and/orchemical material” we also mean in fact any types of analyte, such as,indicatively but not exhaustively, microorganisms, antibodies/antigens,substances developing an antimicrobic action, nucleotides, antibiotics,hormones, sequences of DNA, enzymes, organic materials, biologicalmaterials or materials of biologic origin, enrichment supplements orselective supplements for culture media, and the like, as well as anytypes of chemical substances. Consequently, such definition comprisessamples of different natures intended for a subsequent analysis in theclinical, chemical, biological, microbiological, environmental, genetic,forensic fields and the like. Also, in this text the terms “deformablematerial” and “elastically deformable material”, which a first coatinglayer of a collection portion of the device 20 is made from, shall beconstrued as a material that is capable of deforming to an appreciableextent following a stress manually applied by a user to the collectiondevice 20 to make the collection portion of the collection device 20 andhere to a storage medium, such as a storage paper, or another mediumused to store samples of a biological and/or chemical material commonlyused in this sector. The storage paper can be made from cellulose, orfrom another material suitable for this purpose. More specifically, the“elastically deformable material” which the first coating layer is madefrom shall be capable of deforming upon getting in contact with suchstorage medium to increment the adhesion and the surface of exchangebetween the collection portion, and in particular of the first andsecond coating layer, and the support surface of the storage medium putin contact with such layers. Also, by this term “elastically deformablematerial” we mean a material having a greater deformability with respectto the material that the support body 21 of the collection device 20 andits first end are made from. Finally let's point out that in thiscontext the wording “device for collecting, transferring, and storingsamples of a biological and/or chemical material” does not include thosedevices, typically disposable but even re-usable after washing, whichare solely configured and intended for cleaning portions of a user'smouth, and not specifically to collect samples for analytical purposes,for instance for laboratory, forensic and/or medical applications,consequently this definition does not include, for instance, toothpicksand devices for tongue, tooth, and gum cleaning. The device 20 forcollecting, transferring, and storing samples of a biological and/orchemical material comprises at least one support body 21, developingalong a main longitudinal direction 22 from a first end 23 to a secondend 24 opposite to each other and interconnected by an intermediateportion 25 featuring an elongate shape in the main longitudinaldirection 22. The support body 21 is preferably made from asubstantially rigid or partially flexible material and, for instance,from a plastic material. The support body 21 might be for instance madefrom a plastic polymer or co-polyester or polystyrene or nylon/polyamideor another material suitable for this purpose. The device 20 alsocomprise at least one collection portion 26 engaging the first end 23and configured to collect a quantity of a sample of a biological and/orchemical material. The collection portion 26 is configured to collect orabsorb a quantity ranging from 5 to 1000 microliters of a sample.Preferably this quantity ranges from 10 microliters to 500 microliters,and even more preferably from 50 to 250 microliters of a sample. Thecollection portion 26 is defined at least by one first coating layer 26a made from an elastically deformable material realized on the first end23 and by at least one second coating layer 26 b consisting of a layerof flocked fibers, the second coating layer 26 b being realized througha fiber flocking process on the first coating layer 26 a and beingconfigured to absorb a quantity of liquid comprising at least one sampleof a biological and/or chemical material. The collection portion 26 isconfigured to collect or absorb a substantially known quantity of asample, and in particular the fibers are arranged on the first coatinglayer 26 a so as to define a plurality of capillary interstices suitablefor absorbing the sample by capillarity. Preferably is a first layer ofadhesive material arranged between the first coating layer 26 a and thefirst end 23 to attach the first coating layer 26 a at least to thefront face of the first end 23. Alternatively, a step might be providedof heating the material of the first end 23 and/or of the first coatinglayer 26 a so as to make such materials capable of stably adhering toeach other even after their cooling down. Preferably is a second layerof adhesive material provided between the first coating layer 26 a andthe second coating layer 26 b, to make it possible for the flockedfibers to adhere to the first coating layer 26 a, during the flockingprocess. The adhesive material might be, for instance, a vinylicadhesive or an adhesive of another type suitable for this purpose. Inthis case too, as an alternative, there might be provided a step ofheating the material of the first coating layer 26 a so as to make suchmaterial suitable for determining the adhesion of the fibers in a stablemanner even after their cool down. The second coating layer 26 b formedof a flocking layer can be realized for instance according to theteachings of the already mentioned patent EP1608268B1 or patentapplications WO2014/049460 and WO2014/207598, on behalf of thisApplicant, and whose content concerning the type of the fibers used andthe arrangement and characteristics of the layer of flocking fibers isincorporated in the present text for reference. Specifically, the fibersare arranged by the flocking process on the first coating layer 26 a ina substantially orderly manner. Preferably are the fibers arranged onthe first coating layer 26 a so as to form a substantially continuouslayer. The fibers preferably feature a count ranging from 1 to 10 dtex,or from 2 to 7 dtex, or from 3 to 5 dtex. The fibers preferably featurea length ranging from 0.2 mm to 3 mm, or from 0.4 mm to 2 mm, or from0.6 mm to 1.5 mm. The fibers can be made, for instance, from a polyamide(PA or nylon) and/or rayon and/or polyester and/or carbon fiber and/oralginate and/or natural fiber and/or cotton and/or a mix of suchmaterials. The collection portion 26 can feature, for instance, asurface density of fibers on the first coating layer 26 a ranging from50 to 1,000 fibers per mm² or from 100 to 500 fibers per mm². The firstend 23 preferably features a shape, transversally to the mainlongitudinal direction 22 widened, with respect to the intermediateportion 25, and is provided at least with one front face 23 a and onerear face 23 b, reciprocally facing each other. Preferably the frontface 23 a and/or the flocked portion and/or the rear face 23 b feature asubstantially flat configuration. Alternatively, the front face 23 aand/or the flocked portion and/or the rear face 23 b might feature aconfiguration defined by a curved surface. Preferably is such curveconvex. The front face 23 a and the rear face 23 b can be substantiallyequal to each other and/or symmetrical. The thickness of the first end23, as measured between the first face and the second face and/or in adirection perpendicular to the first face and/or to the second face, canrange from 0.5 mm to 5 mm, or from 0.7 to 4 mm, or from 1 to 2.5 mm. Thesurface of the front face 23 a and/or of the rear face 23 b can rangefrom 20 mm² to 1250 mm², or from 80 mm² to 700 mm², or from 120 mm² to400 mm². The width 30 of the front face 23 a and/or of the rear face 23b, in a direction perpendicular to the main longitudinal direction 22,can range from 5 mm to 40 mm, or from 10 mm to 30 mm, or from 12 mm to22 mm. Such length coincides with the diameter of such faces, should thelatter feature a circular shape, as illustrated. The collection portion26 can have a length 31 ranging from 5 mm to 40 mm, or from 10 mm to 30mm, or from 15 mm to 25 mm, or from 12 mm to 20 mm. The collectionportion 26 is engaged at least to the front face 23 a of the first end23 and the first coating layer 26 a and the second coating layer 26 bare present at least on a portion of the front face 23 a of the firstend 23. In the preferred embodiment, the collection portion 26 isuniquely defined on the front face 23 a of the first end 23 and isabsent on the rear face 23 b, as illustrated in the attached figures. Ina variant not shown here, the collection portion 26 can also be definedon the rear face 23 b of the first end 23. In one embodiment, the firstlayer 26 a is made from a liquid-impermeable and/or hydrophobicmaterial. In one embodiment, the first layer 26 a is liquid-impermeable.In one alternative embodiment, the first coating layer 26 a can be madefrom a liquid-absorbing and/or spongy material. In particular, the firstlayer 26 a can be a liquid-absorbing one and have an additionalabsorbing capability with respect to an absorbing capability of thesecond coating layer 26 b. The first coating layer 26 a can, forinstance, be made from an elastomeric material. The absorbing capabilityof the collection portion 26 can be fully defined by the second layercoating layer 26 b alone, for instance in the case the first coatinglayer 26 a is liquid-impermeable. The second coating layer 26 b can beconfigured to collect or absorb a quantity ranging from 5 to 1000microliters, or from 10 microliters to 500 microliters, or from 50 to250 microliters of a sample. In a preferred embodiment, as illustratedin the figures, the first coating layer 26 a covers the first end 23only partially, and in particular it covers the front face 23 a only ofthe first end 23. Alternatively, the first coating layer 26 a can fullycover the front face 23 a of the first end 23, or in other alternativesit can fully covers the rear face 23 b too or the complete first end 23.In the embodiment here illustrated, the second coating layer 26 b fullycovers the first coating layer 26 a, both in correspondence with onefront face 23 a thereof, and in correspondence with a lateral surfaceperpendicular to the front face 23 a.

In a variant, not illustrated here, the second coating layer 26 b cancover the first coating layer 26 a only partially. In the variantwherein the first coating layer 26 a is also present on the rear face 23b of the first end 23, the first coating layer 26 a can cover the rearface of the first end 23 only partially. The thickness 32 of the firstcoating layer 26 a is preferably less than 6 mm, or less than 5 mm, orless than 4 mm, or less than 3 mm. The thickness 32 of the first coatinglayer 26 a is preferably greater than 0.5 mm, or greater than 1 mm, orgreater than 2 mm. The thickness 33 of the second coating layer 26 b ispreferably less than 3 mm, or less than 2 mm, or less than 1.5 mm. Thethickness 33 of the second coating layer 26 b is preferably less than0.2 mm, or greater than 0.4 mm, or greater than 0.6 mm. In analternative embodiment, not illustrated here, the first coating layer 26a can be formed of a plurality of separate sub-portions and/or beprovided with a plurality of pre-indented sub-portions. For instance,the first coating layer 26 a can be provided with indentations cut insuch a way as to define a plurality of at least partially separatesub-portions, so as to make the detachment of at least one singlesub-portion of the first coating layer 26 a, and of the correspondingsub-portion of the second layer 26 b, from the first end 23 easier at atime following sample collection. The support body 21 is preferablyprovided, for instance in correspondence with the intermediate portion25, with a coupling portion 27. In particular, the collection device 20can be a buccal collecting swab or a buccal or lingual one. In thepresent text, by “buccal” we mean a collection of a biological samplethat is made in a patient's mouth, and consequently also comprises alingual collection or the like. In any case, the concepts herein mightfind applications, in one or more of its aspects, for collections oftypes different from buccal collection, for instance for collections inother cavities of the body or for collections blood samples. A detaileddescription of a preferred explanatory embodiment of a kit forcollecting, transferring, and/or storing samples of a biologicalmaterial, identified by the reference numeral 1 as a whole, is providedbelow. This kit comprises at least one housing body 2 having at leastone housing seat 3 for a storage element 4 for samples of a biologicalmaterial. The housing seat 3 is configured to make it possible toremovably house the storage element 4 for samples of a biologicalmaterial. The storage element 4 is preferably a chemically treated papersuitable for storing samples of a biological material, and in particulara paper comprising at least one substance capable of storing a sample ofa biological material, in particular suitable for storing a buccalsample. Alternatively, the element 4 might be a different medium typesuitable for this purpose. The housing seat 3 can consequently beconfigured to make it possible to removably house such chemicallytreated paper for storing biological samples, and preferably it isconfigured as a lateral opening of the housing body 2 into which thepaper can be slidingly inserted. The housing body 2 is configured tohave at least one storage portion 5 of the storage element accessiblefor depositing a sample of a biological material whenever the storageelement is housed in the housing seat 3, for instance by way of a frontopening, with respect to the mentioned lateral opening. The kit 1 alsocomprises an operating portion 6 movable at least between a firstclosing position wherein it is arranged close to the housing seat 3 andat least one opening position wherein it is arranged in a positionspaced away from the housing seat 3. The kit 1 also comprises anengagement element 7 configured to selectively and removably engage acollection device 20 of the above illustrated type to the kit 1, and inparticular to the housing body 2 and/or to the operating portion 6. Thedevice 20 is selectively and removably couplable with the engagementelement 7 by way of the coupling portion 27. Further characteristics ofthe collecting kit and further variants, equally applicable incombinations with the concepts herein, are illustrated in the alreadymentioned patent application WO2014/001940 (Triva), whose contents, asfar as possible specific embodiments of kit are concerned, isincorporated in the present description for reference. In theembodiments illustrated in the present patent application, theengagement element 7 is configured to selectively and removably engagethe collection device 20 for samples of a biological material to theoperating portion 6, so that the collection device 20 is selectivelyportable, as a consequence of the operating portions 6 being moved, incorrespondence with the housing seat 3 and of the storage portion 5 inthe first closing position and/or so that the collection portion 26 isselectively portable in correspondence with the housing seat 3 and/or incontact with the storage portion 5 in the first closing position. Thekit can also comprise a closure 13 suitable for selectively closing thekit 1 at least in the first closing position, shown in detail in FIG. 8,wherein a contact and a transfer of a biological material take placefrom the collection portion 26 to the storage portion 5. The closure 13is preferably suitable for also defining at least one second closingposition, illustrated in details in FIG. 9, wherein the collectionportion 26 is spaced away from the storage portion 5 and consequentlythere is no contact nor transfer of a biological material between thetwo mentioned portions, the second closing position also advantageouslydefining a storage and/or transfer position of the kit 1. The operatingportion 6 can comprise a closing element or cover 14 suitable for atleast partially covering, at least in the first closing position and/orin the second closing position, the housing seat 3 and/or for at leastpartially covering and protecting the storage element 4 for samples of abiological material housed in the housing seat 3 and/or for covering andprotecting the storage portion 5 for samples of a biological materialduring the storage and/or transfer of the kit and/or at least in thesecond closing position and/or at least in the second mounting position.The operating portion 6 can be engaged in a non-removable manner to thehousing body 2, for instance it can be made as one-piece with thehousing body 2. In one variant, the operating portion 6 can be removablyengaged to the housing body 2. In the embodiments illustrated in theattached figures, the operating portion 6 is joined to the housing body2 by an elastically deformable connection portion 15. In one variant,the connection portion 15 can be plastically deformable. At least thehousing body 2, the operating portion 6, the engagement element 7, theconnection portion 15, the collection device 20 and/or the couplingportion 27 are preferably made from a plastic material. For instance,the housing body 2, the operating portion 6, the engagement element 7,and the connection portion 15 can be made from polypropylene, whereasthe collection device 20 and/or the coupling portion 27 can be made forinstance from polystyrene. The engagement element 7 can comprise forinstance a coupling seat 16 wherein the coupling portion 27 of thecollection device 20 is selectively, slidingly and/or snap-in, and/orrotationally inserted, or in another manner suitable for this purpose.In one variant, the coupling portion 27 can be inserted into a couplingseat 16 defining a sliding guide suitable for allowing for a translationof the collection device 20 with respect to the housing body 2 and/or incorrespondence with the storage element 4. Vice versa, alternatively, acoupling seat might be provided on the collection device and a couplingportion might be provided on the engagement element 7. The closure 13can comprise at least one attachment portion 17 realized on theoperating portion 6 and at least one attachment seat 18 realized on thehousing body 2. Vice versa, alternatively, an attachment seat might beprovided on the operating portion 6 and an attachment portion might beprovided on the housing body 2. The closure 13 can comprise at least twoseparate attachment portions 17 a, 17 b selectively engageable in theattachment seat 18, to define the first and second closing positionsrespectively. The closure 13 can comprise at least two separateattachment seats 18 a, 18 b with the attachment portion 17 to define thefirst and second closing positions respectively. In the embodiment hereillustrated, the attachment portion 17 comprises at least two separateattachment zones 17 a, 17 b, suitable for engaging each a respectiveseparate attachment seat 18 a, 18 b to define the first and secondclosing positions respectively (illustrated in FIGS. 8 and 9respectively). The kit 1 can also comprise a bulging element 19 of themovable element 6 suitable for acting onto the collection portion 26 toforce it in contact with the storage portion 5 and make it possible anoptimum and as much uniform as possible transfer of a biologicalmaterial.

The concepts herein also concern a method to implement a device 20 forcollecting, transferring, and storing samples of a biological and/orchemical material of the above described type. The method comprises atleast the following steps: realizing the support body 21 including atleast the first end 23, the second end 24, and the intermediate portion25; realizing the collection portion 26 on the first end 23 of thesupport body 21, by realizing and securing the first coating layer 26 ato the first end 23 and by realizing the second coating layer 26 b byflocking a layer of fibers onto the first coating layer 26 a. Thesupport body 21 can be for instance realized by injection molding orextrusion. The method can also comprise a step of gluing the firstcoating layer 26 a to the first end 23. The step of flocking the secondcoating layer 26 b onto the first coating layer 26 a can be performedeither before or after applying the first coating layer 26 a to thefirst end 23 of the support body 21. For instance, the step of flockingthe second coating layer 26 b onto the first coating layer 26 a can beperformed on a sheet of the first coating layer 26 a and the sheet cansubsequently be cut into portions of appropriate dimensions andsubsequently applied to the first end 23 of the support body 21.Preferably are the fibers arranged on the first coating layer 26 a by aflocking process in an electrostatic field, preferably in asubstantially perpendicular manner to the surface of the first coatinglayer 26 a. The fibers can be arranged on the first coating layer 26 aexclusively in correspondence with the front surface of the firstcoating layer 26 a, or even in correspondence with a lateral surface ofthe first coating layer 26 a, perpendicular to the front surface, asillustrated in the figures. In one variant, the method can also comprisea step of indenting or dinking the first coating layer 26 a to define aplurality of sub-portions of the first coating layer 26 a. Such step ofindenting or dinking is preferably performed so as to realizeindentations developing in a direction perpendicular to the surface ofthe first coating layer 26 a intended for receiving the second coatinglayer 26 b. The indenting or dinking step can be performed either beforeor after applying the first coating layer 26 a to the first end 23 ofthe support body 21. Such step can for instance be performed by cuttingthe first coating layer 26 a down to a depth less than the overallthickness of the first coating layer 26 a, so as not to completelyseparate the sub-portions of the first support layer 26 a, oralternatively it can be performed by cutting the first coating layer 26a all along the depth of the overall thickness of the first coatinglayer 26 a, so as to completely separate the sub-portions of the firstcoating layer 26 a. The indenting or dinking step can be performedbefore applying the second coating layer 26 b onto the first coatinglayer 26 a. This step can be performed after applying a second layer 26b of adhesive material, suitable for allowing for the adhesion of thesecond coating layer 26 b onto the first coating layer 26 a, onto thefirst coating layer 26 a and before realizing the second coating layer26 b on the first coating layer 26 a. Such step can be performed beforeapplying a second layer 26 b of adhesive material, suitable for allowingfor the adhesion of the second coating layer 26 b onto the first coatinglayer 26 a, onto the first coating layer 26 a and before realizing thesecond coating layer 26 b onto the first coating layer 26 a.Alternatively such step can be performed after applying the secondcoating layer 26 b onto the first coating layer 26 a. The conceptsherein also concern a method for collecting, transferring, and/orstoring samples of a biological material by a device 20 and/or a kit 1of the above-mentioned type. The method can comprise for instance atleast the following steps: collecting a sample of a biological materialonto at least one collection portion 26 of a collecting element 20,preferably a buccal sample. If the first coating layer 26 a isimpermeable, the quantity of the sample is fully absorbed by the secondflocked coating layer 26 b, whereas in the case the first coating layer26 a is also absorbing, then an additional quantity of liquid comprisingthe sample can be collected therein. The method also comprises the stepof subsequently and selectively coupling the collection device 20 with ahousing body 2 or with a movable operating portion 6 of the kit 1, thenbringing the collection portion 26 of the collection device 20 incontact with a storage portion 5 of a storage element 4 for samples of abiological material housed in a housing seat 3 of the housing body 2 totransfer a quantity of the biological material from the collectionportion 26 of the collection device 20 to the storage portion 5. Thanksto the presence of the first deformable coating layer 26 a, an optimumcompression is made of the second flocked coating layer 26 b andconsequently is possible to optimize the transfer of the collectedquantity of sample, even in the case the first layer 26 a is impermeableand/or the sample has not been absorbed. If the first layer 26 a is alsoan absorbing one, and consequently it absorbed an additional quantity ofliquid comprising the sample, a part of such additional quantity canalso be released towards the storage portion 5 thanks to the pressureexerted during transfer. This method can also comprise a step ofsubsequently moving the collection portion 26 away from the storageportion 5 of the storage element 4 to bring the kit 1 to a storageand/or transfer position. The method can also comprise a step of storingthe sample of a biological material on the storage portion 5 for aperiod of time, the kit 1 being preferably configured in a storage ortransfer position. The method can also comprise a step of removing oneor more of the separate and/or pre-indented sub-portions from thecollection portion 26, for a separate use of a part of the collectedsample. The concepts herein also concern the use of a device 20 and/or akit 1 of the above-mentioned type, for collecting, transferring, and/orstoring a sample of a biological material and/or for a buccalcollection, transfer, and storage of a sample of a buccal biologicalmaterial. The concepts herein make it possible to achieve at least oneor more of the following advantages. First of all, the concepts hereinmake it possible to solve one or more of the problems encountered in theknown art. The concepts herein also guarantee a reliable and fullytraceable storage of the collected sample. The concepts herein alsoprovide a high reliability in any operating conditions and as muchindependently as possible of the modes of use by a specific professionaluser. The concepts herein also allow for an optimum transfer of a samplecollected from a collection device to a storage paper or to anotherstorage or analysis medium. The concepts herein are also easy to use.The concepts herein also allow to reduce the risk of contaminating thecollected samples. Finally, the concepts herein are simple andeconomical to implement.

1. A device for collecting, transferring, and storing samples of abiological and/or chemical material, wherein the device comprises: asupport body, developing along a main longitudinal direction between afirst end and a second end opposite to each other and connected by anintermediate portion elongate in the main longitudinal direction, acollection portion engaging the first end and configured to collect aquantity of a sample of a biological and/or chemical material, thecollection portion being defined at least by one first coating layerrealized on the first end and made from a deformable material,preferably an elastically deformable material, and by one second coatinglayer consisting of a layer of flocked fibers, the second coating layerbeing realized through a fiber flocking process onto the first coatinglayer and being configured to absorb a quantity of liquid including atleast one sample of a biological and/or chemical material.
 2. A deviceaccording to claim 1, wherein the first end has a widened shapetransversally to the main longitudinal direction with respect to theintermediate portion, and is provided at least with one front face andone rear face opposed to each other, the collection portion engaging atleast the front face of the first end and the first coating layer andthe second coating layer being present at least on one part of the frontface of the first end.
 3. A device according to claim 1, wherein thefirst end has a widened shape transversally to the main longitudinaldirection with respect to the intermediate portion and is provided atleast with one front face and one rear face, opposed to each other,wherein the collection portion is exclusively defined on the front faceof the first end and is not present on the rear face.
 4. A deviceaccording to claims 1, wherein the front face and/or the flocked portionand/or the rear face feature a substantially flat shape.
 5. A deviceaccording to claim from 1, wherein the front face and/or the flockedportion and/or the rear face feature a shape defined by a curved surfaceor by a curved and convex surface.
 6. A device according to claim 1,wherein the collection portion is configured to collect or absorb aquantity ranging from 5 to 1000 microliters, or from 10 microliters to500 microliters, or from 50 to 250 microliters of a sample, or whereinthe second coating layer is configured to collect or absorb a quantityranging from 5 to 1000 microliters, or from 10 microliters to 500microliters, or from 50 to 250 microliters of a sample.
 7. A deviceaccording to claim 1, wherein the first coating layer covers the frontface of the first end only partially, and/or wherein the first coatinglayer covers the rear face of the first end only partially, and/orwherein the first coating layer covers the first end only partially,and/or wherein the second coating layer covers the first coating layeronly partially.
 8. A device according to claim 1, wherein the thicknessof the first coating layer is less than 6 mm, or less than 5 mm, or lessthan 4 mm, or less than 3 mm and/or greater than 0.5 mm, or greater than1 mm, or greater than 2 mm.
 9. A device according to claim 1, whereinthe thickness of the second coating layer is less than 3 mm, or lessthan 2 mm, or less than 1 mm and/or greater than 0.3 mm, or greater than0.45 mm, or greater than 0.6 mm.
 10. A device according to claim 1,wherein the first layer is made from a liquid-impermeable and/orhydrophobic material and/or wherein the first layer isliquid-impermeable and/or wherein the first coating layer is made froman elastomeric material.
 11. A device according to claim 1, wherein thefirst coating layer is made from a liquid-absorbing material and/or aspongy material and/or wherein the first layer is liquid-absorbing andfeatures an additional absorbing capability with respect to an absorbingcapability of the second coating layer and/or wherein the first coatinglayer is made from an elastomeric material.
 12. A device according toclaim 1, wherein the first coating layer consists of a plurality ofseparate sub-portions and/or is provided with a plurality ofpre-indented sub-portions and/or is provided with indentations realizedin such a way as to define a plurality of at least partially separatesub-portions, so as to facilitate the detachment of at least oneindividual sub-portion of the first coating layer, and of acorresponding sub-portion of the second layer, from the first end at atime following sample collection.
 13. A device according to claim 1,wherein the first coating layer is made from one or more of thefollowing materials: synthetic sponge, expanded resin, expandedpolyethylene, EVA, LDPE, expanded polyurethane, polyether, polyester,Stratocell®, Antistatic, foam Plastazote®, rubber mousse, latex,Dryfeel®.
 14. A kit for collecting, transferring, and storing samples ofa biological and/or chemical material, wherein the kit comprises atleast: a housing body having at least one housing seat for a storageelement for samples of a biological material, in particular a paper forstoring samples of a biological material or another medium for storingsamples of a biological material, the housing seat being configured tomake it possible to removably house the storage element for samples of abiological material, the housing body being configured to keep at leastone storage portion of the storage element accessible for the depositionof a sample of a biological material whenever the storage element ishoused in the housing seat; an operating portion movable at leastbetween a first closing position where it is arranged close to thehousing seat and at least one opening position where it is arranged in aposition spaced away from the housing seat; and at least one engagementelement configured to engage a device to the operating portion accordingto claim
 1. 15. A method for realizing a device for collecting,transferring, and storing samples of a biological and/or chemicalmaterial according to claim 1, wherein the method comprises at least thefollowing steps: realizing the support body, including at least thefirst end, the second end, and the intermediate portion; realizing thecollection portion on the first end of the support body, through therealization and attachment of the first coating layer to the first endand through the implementation of the second coating layer by flocking alayer of fibers onto the first coating layer.